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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000720 |
Purpose
To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population. AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it is likely that children may also benefit from this antiviral therapy. In addition, bacterial infections are frequently found in HIV-infected children. Because pooled human serum immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in patients with defects of immunity, it may reduce the rate of bacterial infection in HIV-infected children as well. In this study, AZT will be administered together with IVIG to determine safety, tolerance, and efficacy of the combined treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Globulin, Immune Drug: Zidovudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| Official Title: | A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine |
| Estimated Enrollment: | 250 |
It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population. AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it is likely that children may also benefit from this antiviral therapy. In addition, bacterial infections are frequently found in HIV-infected children. Because pooled human serum immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in patients with defects of immunity, it may reduce the rate of bacterial infection in HIV-infected children as well. In this study, AZT will be administered together with IVIG to determine safety, tolerance, and efficacy of the combined treatment.
The study includes 250 children, 3 months to 12 years of age. All participants receive oral AZT. IVIG or intravenous placebo is administered every 28 days. Patients are followed for the development of serious bacterial infection, as well as for a number of factors relating to safety, tolerance, progression of disease, and survival. This is an outpatient study conducted over a minimum 100-week period. The children are evaluated every 2 weeks for the first 8 weeks, and monthly thereafter.
Eligibility| Ages Eligible for Study: | 3 Months to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Children must have one or more of the indicator diseases of AIDS; however, there must be an absence of acute opportunistic infection and an absence of bacterial infection requiring treatment at the time of entry into the study.
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following will be excluded:
Concurrent Medication:
Excluded:
Patients with the following will be excluded:
Prior Medication:
Excluded within 4 weeks of study entry:
Active alcohol or drug abuse.
Contacts and Locations
Hide Study Locations| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| Children's Hosp of Oakland | |
| Oakland, California, United States, 946091809 | |
| Kaiser Permanente / UCLA Med Ctr | |
| Downey, California, United States, 902422814 | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| Children's Hosp of Los Angeles/UCLA Med Ctr | |
| Los Angeles, California, United States, 900276016 | |
| Cedars Sinai / UCLA Med Ctr | |
| Los Angeles, California, United States, 900481804 | |
| Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| Martin Luther King Jr Gen Hosp / UCLA Med Ctr | |
| Los Angeles, California, United States, 900593019 | |
| Long Beach Memorial (Pediatric) | |
| Long Beach, California, United States, 90801 | |
| Stanford Univ School of Medicine | |
| Menlo Park, California, United States, 94025 | |
| Northern California Pediatric AIDS Treatment Ctr / UCSF | |
| San Francisco, California, United States, 94143 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| United States, Connecticut | |
| Univ of Connecticut Health Ctr / Pediatrics | |
| Farmington, Connecticut, United States, 06032 | |
| United States, Georgia | |
| Emory Univ School of Medicine | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Illinois College of Medicine | |
| Chicago, Illinois, United States, 60612 | |
| United States, Louisiana | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Univ of Maryland at Baltimore / Univ Med Ctr | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New Jersey | |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 071072198 | |
| United States, New York | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| Metropolitan Hosp Ctr | |
| New York, New York, United States, 10029 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| Columbia Univ Babies' Hosp | |
| New York, New York, United States, 10032 | |
| Beth Israel Med Ctr / Pediatrics | |
| New York, New York, United States, 10003 | |
| SUNY / Health Sciences Ctr at Brooklyn / Pediatrics | |
| Brooklyn, New York, United States, 11203 | |
| Westchester Hosp / New York Med College / Pediatrics | |
| Valhalla, New York, United States, 10595 | |
| Schneider Children's Hosp / Long Island Jewish Med Ctr | |
| New Hyde Park, New York, United States, 11042 | |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
| Elmhurst, New York, United States, 11373 | |
| Lincoln Hosp Ctr / Pediatrics | |
| Bronx, New York, United States, 10451 | |
| United States, North Carolina | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 277103499 | |
| United States, Ohio | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| Columbus Children's Hosp | |
| Columbus, Ohio, United States, 432052696 | |
| Holmes Hosp / Univ of Cincinnati Med Ctr | |
| Cincinnati, Ohio, United States, 452670405 | |
| Univ Hosp of Cleveland / Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Saint Christopher's Hosp for Children | |
| Philadelphia, Pennsylvania, United States, 191341095 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Texas | |
| Hermann Hosp / Univ Texas Health Science Ctr | |
| Houston, Texas, United States, 77030 | |
| Texas Children's Hosp / Baylor Univ | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Children's Hosp of Seattle | |
| Seattle, Washington, United States, 98105 | |
| Puerto Rico | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| UPR Children's Hosp / San Juan City Hosp | |
| San Juan, Puerto Rico, 00936 | |
| Ramon Ruiz Arnau Univ Hosp / Pediatrics | |
| Bayamon, Puerto Rico, 00619 | |
| Study Chair: | Spector, SA |
More Information
| Study ID Numbers: | ACTG 051 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000720 History of Changes |
| Health Authority: | United States: Federal Government |
|
AIDS-Related Opportunistic Infections Placebos Infusions, Intravenous Gamma-Globulins Combined Modality Therapy |
Acquired Immunodeficiency Syndrome Zidovudine Bacterial Infections Immunization, Passive |
|
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Gamma-Globulins Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors Immunoglobulins RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Antibodies HIV Infections Sexually Transmitted Diseases Lentivirus Infections |